Noxopharm receives US FDA feedback supporting SOF-SKN Phase II plans

• FDA feedback supportive of planned approach for a Phase II clinical trial for SOF-SKN
• Feedback provides increased regulatory clarity and helps de-risk SOF-SKN’s development pathway
• Noxopharm will incorporate feedback into preparations for a future IND submission
• Phase II clinical trial targeted for H1 CY28

Noxopharm (ASX: NOX) has received constructive feedback from the US Food & Drug Administration (FDA) for its planned Phase II clinical trial for autoimmune disease drug candidate SOF-SKN.

The company previously formally requested a pre-Investigational New Drug (IND) meeting with the FDA to discuss SOF-SKN’s planned clinical development pathway and requirements for a future IND submission.

Through the pre-IND meeting process, the FDA formally provided its views on Noxopharm’s planned clinical development pathway, along with topics such as clinical trial design, product manufacturing, non-clinical safety studies, and other critical requirements to support a comprehensive IND application.

CEO Dr Olivier Laczka, said at a high level, the FDA was supportive of Noxopharm’s approach and the company’s proposal on how this novel technology could fit into the agency’s regulatory framework. The feedback was particularly supportive of Noxopharm’s chemical manufacturing strategy, and the agency also considered the proposed Phase II trial design as reasonable.

He told shareholders that the FDA also provided technical guidance to ensure alignment with its expectations around the proposed non-clinical studies.

“Engagement with the FDA at this stage is a critical step in our progress along the clinical trials pathway,” Dr Laczka said.

“We appreciate the opportunity to get detailed feedback that will now feed into our Phase II preparations, and look forward to moving this project forward as quickly as possible.

“This outcome is the result of several years of extensive strategic, research, and preparatory work undertaken in close collaboration with industry-leading regulatory experts regarding how the company would develop and present its novel Sofra technology platform to the FDA. The learnings from this process may also help inform future regulatory planning for other Sofra-derived assets.”

Noxopharm is currently in the final preparations for its extension study in patients with cutaneous lupus erythematosus (CLE) in Melbourne. Lupus is an autoimmune disease that can affect different organs, and CLE is a subtype of lupus that manifests in the skin.

There are currently no therapies specifically approved for treating CLE, and there is a significant unmet need for targeted and well-tolerated therapies, while SOF-SKN also represents a potential Orphan Drug Designation opportunity. The global market was valued at US$5.4 billion in 2024.

NOX was steady at 6.2¢  with a Mkt cap of $19.04M prior to markets opening.

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